EP-FENO TABLET 145MG [SIN16155P]

Product Info

EP-FENO TABLET 145MG

[SIN16155P]

4.1. Therapeutic indications:
Hypercholesterolaemia and hypertriglyceridaemia alone or combined (type IIa, IIb, III, IV and V dyslipidaemias) in patients unresponsive to dietary and other non-drug therapeutic measures (e.g. weight reduction or increased physical activity), particularly when there is evidence of associated risk factors such as hypertension and smoking.

The treatment of secondary hyperlipoproteinaemia is indicated if the hyperlipoproteinaemia persists despite effective treatment of the underlying disease (e.g. dyslipidaemia in diabetes mellitus).

Dietary measures initiated before therapy should be continued.

EP Feno 145 mg Tablet is indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy. EP Feno does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.

4.2. Posology and method of administration
Posology:
Adults: The recommended dose is one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200 mg capsule or one 160 mg tablet can be changed to one 145 mg fenofibrate tablet without further dose adjustment.

For hyperlipidaemia indications, response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months (e.g. 3 months), complementary or different therapeutic measures should be considered.

If a patient needs fenofibrate for both hyperlipidemia and diabetic retinopathy indications, only one tablet of fenofibrate 145 mg per day should be taken.

Special population
Geriatric Patients: In elderly patients, without renal impairment, the usual adult dose is recommended.

Renal impairment: Dosage reduction is required in patients with renal impairment.

In moderate chronic kidney disease (creatinine clearance 30 to 59 mL/min), and if a low dose is available, start with one capsule of 100 mg standard or 67 mg micronized once daily.

If no low dose is available, then fenofibrate is not recommended.

In patients with severe chronic kidney disease (creatinine clearance < 30ml/min), EP-Feno 145 mg Tablet is contraindicated.

If during follow-up the creatinine clearance decreases persistently to < 30 ml/min, treatment by EP Feno 145 mg Tablet should be terminated.

Hepatic impairment: EP-Feno 145 mg Tablet is not recommended for use in patients with hepatic impairment due to the lack of data.

Pediatric population: The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore, the use of fenofibrate is not recommended in paediatric subjects under 18 years.

Method of administration:
EP-Feno 145 mg tablet may be given at any time of the day, with or without food (see section 5.2 Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Tablet should be swallowed whole with a glass of water.

4.3. Contraindications:

• Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormalities),

• Known gallbladder disease,

• Severe chronic kidney disease,

• Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia,

• Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen,

• Hypersensitivity to the active substance (s) or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.